Cardiac Magnetic Resonance Image (CMR) in Acute Carbon Monoxide (CO) Poisoning

NCT04419298 | Completed

• 1 other identifier: CMR-CO
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Previous report showed that 37% of patients with moderate to severe carbon monoxide (CO) poisoning experienced a myocardial injury, defined as elevated cardiac enzyme \[creatine kinase, CK-MB, and cardiac troponin I (TnI)\] or ischemic electrocardiogram (ECG) change. In other study, 24% of the patients with the myocardial injury after CO poisoning died during a median follow-up of 7.6 years. The myocardial injury was the major predictor of mortality. In addition, in the Taiwanese nationwide population-based cohort study, CO poisoning itself reported as a higher risk of a major adverse cardiovascular event. According to the previous study of investigators, among CO poisoned patients with myocardial injury, 74.4% of patients experienced CO-induced cardiomyopathy. All CO-induced cardiomyopathy recovered to normal status. In this situation, there is no definite approved reason why more cardiovascular events are occurred in CO poisoned patients with myocardial injury during long term follow-up period despite normalization of CO-induced elevated TnI and cardiac dysfunction. Two image cases related to cardiac magnetic resonance imaging (CMR) in acute CO poisoning previously reported. One image case reported that patient had mildly depressed left ventricular (LV) systolic function with hypokinesis of the anterior wall and regional akinesis of the inferior wall on the transthoracic echocardiography performed during hospitalization and late gadolinium-enhancement (LGE) images of CMR demonstrated multiple focal areas of high signal consistent with myocardial necrosis or fibrosis. Another image case reported an image case that in CMR, inferolateral mid-wall myocardial fibrosis, which was defined as LGE, was present despite the setting of a completely normal echocardiogram at 4-month follow-up in CO poisoned patients. Therefore, the investigators evaluate prevalence (frequency of LGE positive) and patterns (involved LV wall and range of LGE positive) of myocardial fibrosis (LGE positive) in acute CO-poisoned patients during acute (within seven days after CO exposure) and chronic phase (at 4-5 months after CO exposure) and whether LGE positive developed in acute phase have been changed through cardiac MRI performed at chronic phase. The investigators also evaluate LV ejection fraction and global longitudinal strain in transthoracic echocardiography performed at the ED (baseline) and within seven days (follow-up). The investigators also assessed the association between neurocognitive outcomes using the global deterioration scale (at 1, 6, and 12 months after CO exposure) and the presence of LGE positive.

Conditions

Carbon Monoxide Poisoning; Myocardial Injury; Image, Body

Outcome Measures

Primary Outcomes (2)

• Late gadolinium enhancement (LGE) in CMR

  Prevalence (percent) of presence of LGE in CMR

  Within 7 days after acute CO poisoning

• LGE involved wall in CMR

  Injured left ventricular wall according to LGE in CMR

  Within 7 days after acute CO poisoning

Secondary Outcomes (9)

• LGE size in CMR

  Within 7 days after acute CO poisoning

• Change of LGE between first CMR and follow-up CMR

  Within 7 days after CO exposure and at 4-5 months after CO exposure

• LV ejection fraction (EF) of TTE performed at the ED

  Within 3 hours at the ED

• LV global longitudinal strain (GLS) of TTE performed at the ED

  Within 3 hours at the ED

• LV EF of TTE performed during admission

  Within 7 days after CO exposure

Study Arms (1)

Acute CO poisoning with myocardial injury

A diagnosis of CO poisoning was made according to medical history and carboxyhaemoglobin \>5% (\>10% in smokers). Myocardial injury was defined as elevated high-sensitivity TnI level above the upper limit (\> 0.046 ng/mL) when measured in the emergency department (ED) or repeatedly within 24 hours after ED arrival.

Diagnostic Test: Cardiac MRI

Interventions

Cardiac MRI DIAGNOSTIC_TEST

1. Cardiac MRI be taken to acute CO poisoned patients with elevated TnI \[during acute (within 7 days after CO exposure) and chronic phase (at 4-5 months after CO exposure)\] 2. TTE be taken to acute CO poisoned patients with elevated TnI \[At the ED and during admission (within 7 days after CO exposure)\]

Also known as: Transthoracic echocardiography (TTE)

Acute CO poisoning with myocardial injury

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Acute CO poisoning with myocardial injury, which was defined as elevated TnI (reference range \< 0.045 ng/mL), within 24 hours after ED arrival.

You may qualify if:

• Acute CO poisoning with myocardial injury, which was defined as elevated TnI (reference range \< 0.045 ng/mL), within 24 hours after ED arrival.

You may not qualify if:

• Age \<19 years
• No elevated TnI within 24 hours after ED arrival
• Cardiac arrest upon ED arrival or before taking a CMR
• Co-ingestion of cardiac toxic drugs
• Transferred patients without admission
• Declined to enrollment in the study
• Impossible CMR due to artificial device
• Calculated creatinine clearance (Ccr) \< 30 mL/min
• Previous known history of hypersensitivity of gadolinium
• History of acute coronary syndrome, heart failure, or cardiomyopathy
• Patients who refuse CMR or fail to take a CMR although written informed consent was obtained
• Impossible of interpretation of CMR although CMR was taken

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

Related Publications (1)

• Cho DH, Ko SM, Son JW, Park EJ, Cha YS. Myocardial Injury and Fibrosis From Acute Carbon Monoxide Poisoning: A Prospective Observational Study. JACC Cardiovasc Imaging. 2021 Sep;14(9):1758-1770. doi: 10.1016/j.jcmg.2021.02.020. Epub 2021 Apr 14.

  PMID: 33865788 DERIVED

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Gas Poisoning; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 5, 2020
• Study Start: August 1, 2017
• Primary Completion: May 23, 2019
• Study Completion: May 25, 2020
• Last Updated: June 5, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)